くすりのしおり

Internal
Revised: 2/2020

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
Malarone Pediatric Combination Tablets
 Active ingredient:
Atovaquone
Proguanil hydrochloride
 Dosage form:
pale reddish white round tablet, diameter: 7.5 mm, thickness: 3.0 mm
 Print on wrapping:
GX CG7

Effects of this medicine

This medicine combines atovaquone and proguanil hydrochloride, with each drug inhibiting biosynthesis of pyrimidine and deoxythymidylate required for nucleic acid replication through different pathways in malaria parasites, consequently showing anti-malaria parasitic activity.
It is usually used to prevent and treat malaria.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have renal disorder.
  • If you are pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • For treatment: In general, for children, take 2 to 3 tablets according to body weight at a time, once a day, after meal for 3 days. Dosages by body weight are as follows: 2 tablets for 5 to 8 kg; 3 tablets for 9 to 10 kg. Children more than 11 kg take Malarone Combination Tablets.
    For prevention: In general, for children, start taking 1 to 3 tablets at a time, once a day, after meal within 24 to 48 hours before arrival in malaria-endemic areas. Take this medicine after meal every day during your stay in endemic areas and for 7 days after departure from these areas. Dosages by body weight are as follows: 1 tablet for 11 to 20 kg; 2 tablets for 21 to 30 kg; 3 tablets for 31 to 40 kg. Children more than 40 kg take Malarone Combination Tablets.
    In any case, strictly follow the instructions.
  • Avoid taking this medicine on an empty stomach. Take this medicine at the same time each day, after meal or with a milky drink.
  • If you vomit within an hour after taking this medicine, take another dose.
  • If you miss a dose, take the missed dose as soon as possible. You should never take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • If you feel fever of unknown cause during your stay in malaria-endemic areas or after departure from these areas, visit a medical institution immediately.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include abdominal pain, nausea, vomit, headache, itch, diarrhea, cough, constipation, liver dysfunction, hives, abnormal dreams, oral ulceration and stomach discomfort. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • fever, red rash, mucosal eruption with pain in the oral mucosa [muco-cutaneo-ocular syndrome, erythema multiform]
  • loss of appetite, vomit, jaundice [severe liver dysfunction, hepatitis, biliary engorgement]
  • respiratory distress, hives, redness with generalized itching [anaphylaxis]
  • general malaise, headache, dizziness [blood disorder such as pancytopenia]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacy or medical institution on how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.